Bruce A. Buckingham, United States of America

Stanford University Pediatric Endocrinology
• Early researcher in the clinical use of CGM, which I believe is one of the most important advances in the management of type 1 diabetes • Early researcher in automated insulin delivery (AID). AID systems now improve glycemic control, while decreasing the burden of diabetes • Improved control of hyperglycemia mitigates long term complications of diabetes by decreasing non-enzymatic glycosylation and recent MRI and cognitive testing studies show improved neurologic outcomes are associated with decreased hyperglycmeia. • Have worked on the development of infusion sets so they will have extended wear and fewer episodes on unexplained hyperglycemia

Presenter of 3 Presentations

ORAL PRESENTATION SESSION

COMPARING USE OF THE OMNIPOD® 5 SYSTEM WITH 3 MONTHS OF AUTOMATED INSULIN DELIVERY TO 3 MONTHS IN MANUAL MODE: A POST-HOC CROSSOVER ANALYSIS

Abstract

Background and Aims

Achieving treatment goals can be challenging for people with type 1 diabetes (T1D) due to the many daily manual tasks and decisions required. During a 3-month single-arm pivotal study of the Omnipod 5 automated insulin delivery system, a 3-month mid-study safety pause provided the opportunity to assess the system in manual mode (MM, algorithm inactive) compared to automated mode (AM, algorithm active) in a post-hoc crossover analysis.

Methods

A subset of adults (14-70y) and children (6-13.9y) with T1D participating in the study completed four distinct phases of therapy: (1) run-in phase with their standard therapy (ST, 14d), followed by use of the Omnipod 5 System in (2) AM, (3) MM (3mo.), and (4) AM. The total duration of AM use was 3 months per participant (phases 2+4 combined). The primary glucose outcome was percent time in range (TIR, 70-180mg/dL, 3.9-10.0mmol/L).

Results

Adults (N=83) and children (N=89) were aged (mean±SD) 36±14y and 10.5±2.1y with T1D duration 16±11y and 4.8±2.7y and baseline A1C 7.3±0.9% and 7.7±0.9%, respectively. TIR was significantly higher during the AM phases compared to ST and MM (Table). Specifically, TIR increased with AM during Phase 2 compared to ST, reduced back to a level comparable to ST during MM in Phase 3, and then increased again when AM resumed in Phase 4 (all p<0.05).

Conclusions

This post-hoc crossover study emphasizes the effectiveness of the Omnipod 5 automated insulin delivery algorithm on glycemic outcomes, beyond pump and CGM use alone.

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PLENARY SESSION

Omnipod® 5 Automated Insulin Delivery System: Pivotal Trial Results and Ongoing Investigations

INDUSTRY SESSION

Innovation in Infusion Sets: Extending the Wear for a Better Experience